5|25: Celebrating Five Years of Autism Science Day 6: FDA Approval of Risperidone

In honor of the anniversary of Autism Speaks’ founding on Feb 25, for the next 25 days we will be sharing stories about the many significant scientific advances that have occurred during our first five years together. Our sixth item, FDA Approval of Risperidone, is from Autism Speaks’ Top 10 Autism Research Events of 2007.

In late 2006 the U.S. Food and Drug Administration (FDA) approved the first medication indicated to treat certain symptoms associated with autism, making 2007 the first year an approved drug for autism was available. The drug, risperidone sold under the brand name Risperdal, is manufactured and marketed by Janssen, L.P., a subsidiary of Johnson & Johnson.

First introduced in 1993 as an atypical antipsychotic to treat schizophrenia, Risperdal can now be marketed as a treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years. This includes symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums and quickly changing moods. Importantly, Risperdal does not treat the core symptoms of autism such as communication problems and trouble with social interactions. However, J&J used two clinical trials to demonstrate the benefits of the drug in treating the associated behavioral disturbances that can interfere with school, learning and family life.

This event not only sets precedence for gaining FDA approval for medications that treat autistic symptoms, it also shows that autism is considered a viable market for the pharmaceutical industry which will hopefully lead to the development of new compounds that will benefit the quality of life for those living with autism.

Update since this story was first run: On November 20, 2009 the FDA approved Abilify (aripiprazole) for the treatment of irritability associated with autism, making it the second medication to receive an autism indication. Specifically, the drug is approved for children 6-17 to help alleviate symptoms of “aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.” Aripiprazole, which is manufactured and marketed as Abilify by Bristol-Myers Squibb, is an atypical antipsychotic medication used to treat schizophrenia, bipolar disorder and depression. Although an FDA approval for a medication addressing the core symptoms of autism is still lacking, the approval of Abilify will offer additional options for families and clinicians.